B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
Conditions
Interventions
None listed
Sponsors
ViiV Healthcare UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Ability to understand and sign a written informed consent form b) Men and non-pregnant women with chronic HIV-1 infection c) Age 18 years and older d) Subject Re-enrollment: If re-enrolled, the subject must be re-consented. e) Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes f) Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA =400 c/mL (first value from Investigator, second from Screening labs) g) Must have = 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety concerns h) Willingness to use approved highly effective methods of contraception to avoid pregnancy (men and women of child bearing potential only). i) Males and Females, ages 18 years of age or older. j) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test . k) Women must not be breastfeeding l) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with the Attachment Inhibitor plus 5 half-lives of study drug BMS-663068 (2 days) plus 30 days (duration of ovulatory cycle) for a total of 40 days post-treatment completion. m) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with the Attachment Inhibitor plus 5 half-lives of the study drug BMS-663068 (2 days) plus 90 days (duration of sperm turnover) for a total of 100 days post-treatment completion. n) Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.
Exclusion criteria
Exclusion criteria: a) Any other clinical condition (including but not limited to substance use) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study. b) Chronic untreated HBV (however, patients with chronic treated HBV are eligible) c) HIV-2 infection d) ALT or AST > 7 x ULN e) Alkaline Phosphatase > 5 x ULNf f) Bilirubin = 1.5 x ULN g) History of decompensated cirrhosis or active decompensated cirrhosis h) History of congestive heart failure or congenital prolonged QT syndrome i) Hemoglobin 500 msec at Screening or Day 1 l) Confirmed QTcF value > 470 msec for women and > 450 msec for men at Screening or Day 1 m) Confirmed PR Interval > 260 msec (severe first degree AV block) at Screening or Day 1 n) Confirmed second or third degree heart block at Screening or Day 1 o) Current or anticipated treatment with any of the following medications: rifampin, Hypericum perforatum (St. John’s wort), efavirenz, nevirapine, ketoconzole, carbemazepine, phenobarbital, phenytoin, grapefruit juice, rosuvastatin, simvastatin, atorvastatin, fluvastatin, pivastatin p) Participation in an experimental drug and/or HIV-1 vaccine trial(s) within the previous 30 days (Randomized Cohort only) q) Prisoners or subjects who are involuntarily incarcerated r) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, Norway, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kindgdom, United States
Outcome results
None listed